The Use of VSL#3 in Irritable Bowel Syndrome in Children (VSL#3)

The goal of this study is to determine whether the oral administration of the probiotic VSL#3 under randomized, placebo-controlled conditions will improve symptoms of irritable bowel syndrome in children, safely.

Study Overview

• Status: Terminated
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Other: Placebo; Drug: VSL#3 90 billion bacteria; Drug: VSL#3 900 billion bacteria

Detailed Description

Determine the safety and efficacy of different doses of VSL#3 in the treatment of children with irritable bowel syndrome: Children will be recruited from the pediatric gastroenterology clinic at The Children's Medical Center in Dayton, Ohio. Eighty four children will be enrolled in this controlled, double-blinded, randomized study. All children will have had a prior evaluation by a pediatric gastroenterologist who has diagnosed these patients with irritable bowel syndrome and excluded organic disease as a cause of the child's abdominal pain.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Dayton, Ohio, United States, 45404
      • Children's Medical Center of Dayton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All children should fulfill Rome ll criteria for IBS.
• Organic disease has been excluded.
• Age 13-18 years.
• Have active symptoms for at least 2 weeks prior to randomization. A minimum of 4.0 on the 7-point Likert scale for the two weeks prior to randomization on the GSRS-IBS composite pain score will be required.
• Diarrhea predominant IBS: Diarrhea is defined as increased stool frequency more than 3 times daily or change in form to loose or watery stools.

Exclusion Criteria:

• Children not fulfilling the inclusion criteria.
• Children receiving medication for the treatment of irritable bowel syndrome within 2 weeks of randomization.
• Children receiving antibiotic therapy or other probiotic agents within 4 weeks of randomization.
• Children receiving other medication known to cause abdominal pain.
• Children diagnosed with any of the following GI disorders: IBD (Crohn's disease or UC), Celiac disease, Gastroparesis, abdominal adhesions, Gastrointestinal perforation, Gastrointestinal obstruction and/or stricture, chronic or recurrent pancreatitis.
• Children who had undergone previous abdominal surgery (with the exception of uncomplicated appendectomy or cholecystectomy greater than or equal to 6 months prior to enrollment).
• Children with a history of any disease that may affect bowel motility such as diabetes mellitus, or poorly controlled hypo/hyperthyroidism.
• Children with immune deficiency, on immune-suppressants, or have active psychiatric, neurological, metabolic, renal, hepatic, infectious, hematological, cardiovascular or pulmonary disease.
• Children with a history of malignancy.
• Pregnancy.
• Children with history of allergy to maize or probiotics.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Other: Placebo; One packet PO daily x 8 weeks.; Other Names: VSL#3
ACTIVE_COMPARATOR: VSL#3 90 billion bacteria	Drug: VSL#3 90 billion bacteria; One packet PO daily, x 8 weeks.; Other Names: VSL#3
ACTIVE_COMPARATOR: VSL#3 900 billion bacteria	Drug: VSL#3 900 billion bacteria; One packet PO daily, x 8 weeks; Other Names: VSL#3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Gastrointestinal Symptom Rating Scale	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Coddington life events questionnaire	8 weeks

Collaborators and Investigators

• Sponsor: Dayton Children's Hospital
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Sonia Michail, MD, Wright State University, Children's Medical Center of Dayton

Publications and helpful links

General Publications

• APLEY J, NAISH N. Recurrent abdominal pains: a field survey of 1,000 school children. Arch Dis Child. 1958 Apr;33(168):165-70. doi: 10.1136/adc.33.168.165. No abstract available.
• Everhart JE, Renault PF. Irritable bowel syndrome in office-based practice in the United States. Gastroenterology. 1991 Apr;100(4):998-1005. doi: 10.1016/0016-5085(91)90275-p.
• Hamm LR, Sorrells SC, Harding JP, Northcutt AR, Heath AT, Kapke GF, Hunt CM, Mangel AW. Additional investigations fail to alter the diagnosis of irritable bowel syndrome in subjects fulfilling the Rome criteria. Am J Gastroenterol. 1999 May;94(5):1279-82. doi: 10.1111/j.1572-0241.1999.01077.x.
• King TS, Elia M, Hunter JO. Abnormal colonic fermentation in irritable bowel syndrome. Lancet. 1998 Oct 10;352(9135):1187-9. doi: 10.1016/s0140-6736(98)02146-1.
• Bengmark S. Ecological control of the gastrointestinal tract. The role of probiotic flora. Gut. 1998 Jan;42(1):2-7. doi: 10.1136/gut.42.1.2. No abstract available.
• Nobaek S, Johansson ML, Molin G, Ahrne S, Jeppsson B. Alteration of intestinal microflora is associated with reduction in abdominal bloating and pain in patients with irritable bowel syndrome. Am J Gastroenterol. 2000 May;95(5):1231-8. doi: 10.1111/j.1572-0241.2000.02015.x.
• Svedlund J, Sjodin I, Dotevall G. GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci. 1988 Feb;33(2):129-34. doi: 10.1007/BF01535722.
• Balsari A, Ceccarelli A, Dubini F, Fesce E, Poli G. The fecal microbial population in the irritable bowel syndrome. Microbiologica. 1982 Jul;5(3):185-94.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (ACTUAL): August 1, 2011
• Study Completion (ACTUAL): August 1, 2011

Study Registration Dates

• First Submitted: July 2, 2009
• First Submitted That Met QC Criteria: July 2, 2009
• First Posted (ESTIMATE): July 3, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): March 20, 2012
• Last Update Submitted That Met QC Criteria: March 16, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: 04-007; R21AT003400-01A2 (NIH)